Blistered rapid diagnostic test with incorporated moisture absorbent material

ABSTRACT

A package which incorporates, integrated in the composition of one of the components of the test package, a plastic support ( 1 ), a moisture absorbing agent, so that this does not affect them, in combination with one or more polymers, which may be packaged in a blister produced by a base sheet ( 7 ) with cavities ( 9 ), in each one whereof a rapid diagnostic test ( 5 ) is placed, whose base sheet ( 7 ) is complemented with a cover sheet ( 8 ) which seals the base sheet by heat fusion, achieving the hermeticity of each cavity.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of U.S.application Ser. No. 11/588,985, filed Oct. 27, 2006, which was a §365(c) continuation application of PCT/ES2005/000235 filed Apr. 29, 2005,which in turn claims priority to ES Application P200401045 filed Apr.30, 2004 and ES Application P 200401085 filed May 6, 2004, each of theforegoing applications is incorporated herein by reference

FIELD OF THE INVENTION

The present invention relates to a rapid diagnostic test package withincorporated moisture absorbent material, which avoids that saidmoisture may affect the test or even invalidate it, giving erroneousresults for the test being performed. Likewise, the invention relates toits form of blister packaging which may be formed in unit form orcomprising several units which can be separated from one another.

The object of the invention is, therefore, to provide a new rapiddiagnostic test package which incorporates the moisture absorbentmaterial in its own structure, which permits the use of smallerpackaging with the consequent reduction in packaging costs, in additionto its smaller transport volume and the smaller surface of moisturepermeation from the exterior, this being achieved by suitable blisterpackaging which permits its properly sealed commercialization.

BACKGROUND OF THE INVENTION

Currently, there are various products to perform rapid diagnostic testsand new ones are created every day. The best-known ones areimmunochromatographic tests, and within these the best known are perhapsrapid pregnancy tests. The great problem with all these types of rapiddiagnostic tests is that moisture considerably affects them, changingtheir characteristics and properties, and may even possibly invalidatethem. Therefore, in addition to using packaging, e.g. aluminum orplastics, which guarantee hermeticity to moisture penetration, a type ofmoisture absorber, such as silica gel, molecular sieve or clay pelletsis always added.

There currently exist two clear types of packaging for these products:those which contain multiple test elements in a single package,generally for hospital use, aluminum bags being the best-known of thistype, wherein a determined number of tests and a pellet or separatesachet with the moisture absorbent material is inserted therein; and, onthe other hand, the known plastic tubes wherein a number of testelements are also inserted, together with the pellet or sachet ofmoisture absorbent material. On some occasions, instead of this,packaging manufacturers exist that incorporate the absorbent material inthe stopper, which logically increases their price. These types ofmultiple test packaging have, among others, the great drawback that oncethe packaging has been opened, it is difficult to guarantee thesubsequent shelf-life of the product contained therein.

On the other hand, packages exist which contain a single test element,generally intended for personal use and, therefore, with clearlydifferent requirements. The packaging used in these cases is an aluminumbag of reduced dimensions, wherein a test element and the sachet orpellet of absorbent material is inserted. This type of single-testpackaging has some different types of drawbacks, e.g. a considerablylarger bag than is necessary so that the sachet or pellet of moistureabsorbent material can easily be inserted therein in the fillingprocess, with the consequent increase in packaging costs.

Furthermore, two different operations are required in the fillingprocess, one to insert the test element in the packaging and the otherto insert the moisture absorbent material, which hinders said packagingprocess. Another drawback they have is that in many cases the use ofthese test elements are geared towards personal use and not towardsqualified personnel, so that there may be confusion in the use of thepellet or sachet of absorbent material instead of the test element, withsubsequent possible implications, and they may even be ingested.

On the other hand, as the size of the packaging bag is considerablylarger than the test element, its transport, very important in thisarea, is considerably affected and its costs are greatly increased.

Finally, the quantity of moisture absorbent material needed is greateras the packaging is larger and, therefore, the moisture permeationsurface will also increase.

The blister packaging system as means of packaging and commercializationof products and/or items is very common in different fields and sectorsof the art, especially in the pharmaceutical sector, nevertheless, inthe diagnostics sector, conventional blister packaging presents seriousproblems and drawbacks since the test elements are seriously affected bymoisture, as previously mentioned. In any case, the blister packagingsystem can be considered as totally rejected in the industrialdiagnostic sector, and probably due to the deficiency of traditionalaluminums, wherein micropores exist, as well as the necessary thicknessfor decent insulation, which involves a large quantity of aluminumnecessary to form the blister, also due to the considerable dimensionsnecessary to blister package the rapid diagnostic test element, togetherwith the moisture absorbent material and the high cost of the machineryto manufacture the blister, as well as for the blister packagingprocess.

ES 2138890 discloses a test device comprises a housing having one ormore reactants which may be damaged by humidity during storage whereinthe housing is made up, at least partially, of plastic materialcontaining moisture absorbent.

U.S. Pat. No. 6,319,466 discloses a test device for detecting thepresence of a residue analyte in a sample includes a support strip and asample-absorbing matrix attached to the support strip. Thesample-absorbing matrix has a material for absorbing an amount of thesample. The test device also includes a mobile-phase support for holdinga mobile-phase composition. The mobile-phase support is attached to thesupport strip and in contact with the sample-absorbing matrix. Amobile-phase composition is disposed on the mobile-phase support and hasa receptor for binding with the analyte. The mobile-phase compositioncan be carried in the sample. A stationary-phase membrane is attached tothe support strip and has a first membrane end in contact with themobile-phase composition and a second membrane end. The membrane allowslateral capillary flow of the sample from the first membrane end to thesecond membrane end. A test zone is on the stationary-phase membranebetween the first membrane end and second membrane end and having afirst binder for binding with an unbound receptor. A control zone is thestationary-phase a membrane between the test zone and second membraneend and has a second binder for binding with an analyte-bound receptoror residual unbound receptor.

SUMMARY OF THE INVENTION

The rapid diagnostic test with incorporated moisture absorbent materialand its form of blister packaging which the invention proposes, resolvesthe aforementioned problem in the different aspects commented in a fullysatisfactorily manner.

Thus, the rapid diagnostic test package claimed is characterized in thatit incorporates a moisture absorbing agent within the test package inone of its constituent parts, or in one of the general structuralcomponents of said test package, which eliminates said moisture duringthe time in which it remains packaged, so that it does not affect orinvalidate it, giving erroneous results when performing the test.

These types of rapid diagnostic tests normally have a plastic support togive them a certain rigidity, or a handling area, so that as theinvention proposes, said support or handling area will be the testcomponent that has the best characteristics to incorporate the moistureabsorber, since it does not directly interfere with the test, andtherefore does not affect its properties as a rapid diagnostic testelement. Said support or handling area combines one or more polymerswith a drying agent, i.e. moisture absorber.

In this way, the support can be formed from a polymer that forms themain part of the composition, e.g. a thermoplastic or thermosettingpolymer, a minority non-miscible polymer with the majority polymer, e.g.a hydrophilic or hydrophobic material and a particle that issubstantially found in the minority polymer, e.g. the active agent, i.e.the moisture absorbing agent.

The support with the incorporated absorbent material can be adhered byany method suitable for the test element, although it will normally beperformed with a double-sided adhesive, which means an additionalbarrier between the test element and the absorbent material found in thebase.

According to another characteristic of the invention, these rapiddiagnostic test packages with incorporated moisture absorbers areblister packaged. Said blister packaging is based on the blister beingformed from two aluminum or plastic sheets, one of them acting as thebase wherein one or several cavities is formed for the correspondingtest package or packages, while the other sheet acts as cover and seal,to close the cavities of the base with the rapid diagnostic testelements therein.

The cover and sealing sheet is fixed on the base sheet, by heat fusion,with the mediation of determined polymeric or other materials thatbelong to the state of the art and which facilitate its fixingthroughout its perimeter, to achieve the hermetic sealing of thedifferent cavities formed in the base sheet, in those cases wherein ithas more than one structure or cavity.

The blister, either as independent unit or as units which are separableor detachable, by a tear line between two consecutive cavities orstructures, will have the surface upon which the sealing or fixing ofthe cover sheet will be performed, provided with embossing by way ofknurling, with the object of permitting better sealing of the coversheet to the base sheet.

We should highlight the fact that the blister has an external punch-holeadjacent to one of the ends of each separable unit, wherefrom the coversheet will be separated from the base sheet, which will facilitate thegrip and, therefore, the pulling to separate or open the blister of thatspecific unit.

In a variant of embodiment, an area or space for control code, expirydate, etc. has been provided collateral to each of the units.

Another variant of practical embodiment would be the blister packagingof the test inserted in a plastic case by way of reaction device, whichis very widely used in the sanitary product sector for in vitrodiagnosis, especially for the rapid diagnostic tests with incorporatedmoisture absorbers of the invention.

Although the material used would, in principle, be aluminum, the use ofother possible materials such as plastics, thermoplastics, etc.,especially those with low vapour permeability, cannot be ruled out.

These types of rapid diagnostic tests with incorporated moistureabsorber has a series of advantages compared to the methods used up tonow to avoid this type of test from being negatively affected bymoisture, such as, for example, advantages due to the smaller size ofthe packaging which makes it easier to transport, only one fillingoperation is required as the humidity absorber is incorporated in thetest, doubt or confusion as to which element or elements are necessaryto perform the test is eradicated for individual users.

The blister packaging system for rapid diagnostic test also has severaladvantages compared to traditional packaging, and among said advantageswe can cite the possibility of forming several detachable units in asingle body, each with its hermetic test, drastically reducing thedimensions of each unit, as well as the manufacturing costs, given thepossibility of making multiple blisters, minimal or practically nullmoisture transfer, reduction in transport costs and commercializationand permanent maintenance of the test's shelf-life as they areindependently sealed.

DESCRIPTION OF THE DRAWINGS

To complement the description being made and with the object of aidingtowards a better understanding of the characteristics of the invention,in accordance with a preferred example of embodiment thereof, a set ofdrawings is attached as an integral part of said description, whereinthe following has been represented, with an illustrative, non-limitingcharacter.

FIG. 1 shows a schematic representation of an immunochromatographic testelement in the format of a reactive strip where, according to the objectof the invention, the moisture absorbent material has been incorporatedin the support.

FIG. 2 shows a plan view of a multiple blister of rapid diagnostictests, object of the invention.

FIG. 3 shows a cutaway view corresponding to the section line of 3-3 inFIG. 2.

FIG. 3A is an enlarged view of the portion encircled at 3A in FIG. 3.

FIG. 4 shows another cutaway view, in this case in accordance with thesection line 4-4 of FIG. 2.

FIG. 5 shows an alternative embodiment of the multiple blisterrepresented in FIG. 2, displaying collateral to each structure or cavityof each unit, a rectangular area for control or printing of any type ofdata or information.

PREFERRED EMBODIMENT OF THE INVENTION

In light of the described figures, and more specifically FIG. 1, we canobserve that the rapid diagnostic test element (5) in the form of areactive strip (2) represented therein is formed on a laminated plasticsupport (1), which gives it the rigidity necessary for its correcthandling. The support (1) is joined to the structure (2) comprising thetest element, by means of a double-sided adhesive (3), adding one ormore protective sheets (4) to the unit, which protect and preventcontamination of the test element (2), thereby avoiding it from beingdamaged and possible errors from occurring in the test results.

The laminated plastic support (1) of the test package is the componentof the package which incorporates the moisture absorbent material, whichwill be comprised of a combination of one or more polymers together withthe drying agent responsible for absorbing the moisture.

As has been previously explained, the test elements (2) can be directlyadhered to the support (1) or, as is shown in FIG. 1, by means of adouble sided adhesive (3), which forms an additional barrier between thetest and the absorbent material, thus avoiding the test beingcontaminated. The test element (2) is shorter than the support (4) sothat one end of the laminated support (1) is uncovered to provide ahandling area (6).

However, a preferred packaging system, represented in FIGS. 2-4, isdeveloped in the invention; it is a blister formed from two sheets (7)and (8), the first acting as base sheet and the second as cover andsealing sheet of the previous, so that the base sheet (7) is providedwith a series of preformed cavities (9), produced by forming, each oneof which is designed to contain a rapid diagnostic test (5), As shown inFIGS. 3A and 4, when the test strip 2 is assembled in the packagingsystem, the preformed cavity may closely embrace the bottom of the teststrip, but will expose the sides and ends of the strip to the air withinthe cavity, which air, in turn, is exposed to the moisture-absorbingmaterial in the support 1, which engages the top of the test strip. Inthis way, any moisture in the air surrounding the test strip is absorbedby the absorbent material in the exposed areas of the support.

Each one of these cavities (9) is delimited with respect to the adjacentone, by a pair of weakened or precut lines (10) which permit separatingeach part or unit determined in the blister.

The cover sheet (8) is fixed to the base sheet (7) by heat fusion, incorrespondence with the entire perimeter, to achieve the hermeticity ofeach of the units determined by the cavities (9) with the test (5)therein, since tearing these weakened or precut lines (10) permitsseparating each unit.

The contact surface of the base sheet (7), whereon the cover sheet (8)is fixed, has embossing (11) by way of knurling, which improves thesealing between both sheets (7) and (8).

Furthermore, adjacent to one of the ends there is a punch-hole (12)wherefrom sheets (7) and (8) are separated, allowing an easy grip andcorresponding pulling of the sheet (8) when said cavity corresponding toeach blister unit is opened. Evidently, other known opening systems inthe blister packaging sector cannot be ruled out.

Having compared the blister packaging disclosed with the traditionalpackaging system, in both cases using aluminum, it has been verifiedthat the traditional packaging in a bag has an aluminum thickness ofapproximately 1 micron, whilst the aluminum used in the blisterpackaging of the invention has an approximate thickness of 20 micronswith regard to the cover or sealing sheet (8), and around 45 microns inthe base sheet (8), so that thickness will be lost when making thecavities (9) in the latter, but it will never be less than the 20microns of the cover or sealing sheet (8).

Although more material is used in the case of the invention and,therefore, it is more expensive, as a consequence of the drasticreduction in size of one packaging system with respect to the other, itmeans that the end cost of the blister packaging is practically the sameas that of the conventional packaging.

Furthermore, we should highlight the fact that, according to theexperiments performed, in traditional packaging the total humidity inthe packaging, after one year, is considerably greater than that of theblister packaging of the invention, being able to consider moisturetransfer in the blister packaging of the invention as zero.

We should also state that the dimensions of the blister packaging withrespect to conventional packaging are considerably reduced in the firstcase, and we can estimate dimensions of 120×60 mm, in conventionalpackaging, compared to approximately 78×5 mm in the blister packaging ofthe invention, which involves considerable differences between themoisture filtration surface of 0.0144 m² in conventional packagingcompared to 0.00078 m² in the blister packaging of the invention, theinitial volume of internal air also being considerably lower, whichlogically has an influence on the initial moisture quantity within thepackaging at the time of sealing.

Specifically, it is calculated that the moisture in the conventionalpackaging, after one year, is 0.377 g compared to 0.008 g in the case ofthe blister packaging of the invention, which has a clear implicationconsisting of less need for moisture absorbent material, and thereforegreater shelf-life of the product in the blister packaging of theinvention.

It should also be highlighted that, as the blister packaging of theinvention is of reduced dimensions with respect to conventionalpackaging, the boxes wherein the products are going to be sent admitbetween 10 and 34 times more units than with traditional packaging,which means a very large reduction in transport costs, and more so forthis type of sector where most of the production is devoted toimportation and exportation.

Finally, we should state that even for the case of multi-tests, theblister packaging of the invention has a clear advantage overtraditional systems, plastic tubes or bags of greater dimensions, as inthese cases once the packaging is open its shelf-life is very difficultto guarantee; in the case of the invention, as the tests areindividually hermetically sealed, the shelf-life is not altered.

FIG. 5 represents an alternative embodiment of the blistered packagealso formed from two corresponding sheets, one a base sheet and theother a cover or sealing sheet, with the cavities (9′) housing therespective test (5′) in each one thereof, so that in this case, eachunit, separated as in the previous case from the adjacent ones bydelimited tear lines (10′), has, collateral to each cavity (9′), an areafor the control code, expiry date information or other type ofinformation, in this case establishing a different opening system, bybreaking.

1. A blistered rapid diagnostic test package characterized in that itcomprises: a base having at least one pre-formed cavity having a spaceadapted to receive a rapid diagnostic test element; a cover structurecooperating with said base adapted to seal said space; a rapiddiagnostic test element in said at least one pre-formed cavity betweensaid base and said cover structure, said test element having sides andends exposed to said sealed space; a moisture absorbing agent integratedin said at least one pre-formed cavity of said test package and exposedto said sealed space; and said cover structure being fixed by heatfusion to said base, so as to provide the seal for said at least onepre-formed cavity containing said rapid diagnostic test element and saidmoisture absorbing agent.
 2. The blistered rapid diagnostic test packageof claim 1 wherein said moisture absorbing agent and at least onepolymer are attached to said test element, and wherein said moistureabsorbing agent and said at least one polymer are enclosed in said atleast one cavity with said test element.
 3. The blistered rapiddiagnostic test package of claim 1 having a handling area spaced fromsaid test element, wherein said moisture absorbing agent is integratedwith said handling area.
 4. The blistered rapid diagnostic test packageof claim 1 comprising a punch-hole adjacent to one end of said preformedcavity whereby said base and said cover structure are separated topermit easy gripping and pulling of said cover structure in an openingoperation of said package.
 5. The blistered rapid diagnostic testpackage of claim 1 wherein said at least one cavity consists of a singlecavity determining a single independent unit accommodating said rapiddiagnostic test element.
 6. The blistered rapid diagnostic test packageof claim 1 wherein said at least one cavity consists of a plurality ofcavities, each cavity defining a unit accommodating a single rapiddiagnostic test element, said units being independently hermeticallysealed and said base comprising a plurality of weakened tear linesbetween each two cavities to facilitate separation of said units.
 7. Theblistered rapid diagnostic test package of claim 1 further comprising anarea where said cover structure is fixed by heat fusion to said base,said base having only one surface with ribs by way of knurling, so as toimprove sealing of said cover structure.
 8. The blistered rapiddiagnostic test package of claim 6, further comprising an area adjacentto said weakened tear lines of each unit and collateral to each of saidcavities, showing printed data selected from control data, informationdata and combinations thereof.
 9. The blistered rapid diagnostic testpackage of claim 1 further comprising adhering means for adhering saidbase to said cover structure and wherein said base is directly adheredto said cover structure by said adhering means.
 10. The blistered rapiddiagnostic test package of claim 1, wherein said test element has asupport, and further comprising adhering means for adhering said supportto said test element, said adhering means comprising a double-sidedadhesive acting as a separation between said test element and saidsupport.
 11. The blistered rapid diagnostic test package of claim 10having a handling area on said support spaced from said test element,wherein said moisture absorbing agent is integrated with said handlingarea.
 12. The blistered rapid diagnostic test package of claim 1 whereinsaid base and said cover structure each comprise aluminum having athickness of at least 20 microns.